An Observational Study of Xeloda (Capecitabine) Monothera... | NCT01276405

Studies
An Observational Study of Xeloda (Capecitabine) Monotherapy in Patients With Colorectal Cancer (AXEL)

NCT01276405

Sponsor

Hoffmann-La Roche

Status

Terminated

Last Update Posted

Nov 2, 2016Estimated

Enrollment

123Actual

Phase

Not provided

Conditions

Colorectal Cancer

Interventions

Not provided

Countries

Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Jan 12, 2011

First Submission Date that Met QC Criteria

Jan 12, 2011

First Posted Date

Jan 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This observational study will evaluate Xeloda (capecitabine) monotherapy on the effect of disease-free survival in patients with colon cancer stage III (Duke C) after surgical resection. Data will be collected for 3 years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

123Actual

Label	Type	Description	Intervention Names
Cohort

Measure	Description	Time Frame
Disease-free survival		3 years

Measure	Description	Time Frame
Safety (Incidence of adverse events)		3 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients, over the age of 18 years
Presence of colon adenocarcinoma
Surgical resection for colon cancer stage III (Duke C)
Prior adjuvant therapy with Xeloda monotherapy

Exclusion Criteria:

Contraindications for Xeloda

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with colon cancer stage III (Duke C) on Xeloda monotherapy

Sampling Method

Probability Sample

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided